Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00520598
First received: August 22, 2007
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)


Condition Intervention Phase
Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Human Papillomavirus Infection
Biological: Comparator: V505 formulation 1
Drug: Comparator: V505 formulation 2
Biological: Comparator: V505 formulation 3
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
Biological: Comparator: Placebo (unspecified)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: No ]

Enrollment: 511
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 2
Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
Biological: Comparator: V505 formulation 1
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 3
Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Experimental: 4
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
Biological: Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Experimental: 5
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
Biological: Comparator: V505 formulation 3
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
Biological: Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

  Eligibility

Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female between 16 to 26 years old
  • Has never had Pap testing or have only had normal Pap test results
  • Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

  • History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
  • History of severe allergic reaction that required medical attention
  • Are pregnant
  • Received a marketed HPV vaccine
  • Currently enrolled in a clinical trial
  • Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520598

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00520598     History of Changes
Other Study ID Numbers: 2007_567, V505-001
Study First Received: August 22, 2007
Last Updated: June 22, 2011
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Tumor Virus Infections
Vaginal Diseases
Condylomata Acuminata
Warts
Papillomavirus Infections
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on July 26, 2014